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NCT00313729 · REGISTRY CONDITION SEARCH

Temozolomide in Treating Patients With Low-Grade Glioma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2019-02-07

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with supratentorial low-grade glioma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Response Rate (Complete and Partial Response)

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outcome · POSTED

Time to Tumor Progression

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outcome · POSTED

Safety Profile

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Histologically proven supratentorial low-grade (grade II) glioma of any of the following histologic subtypes: * Oligodendroglioma * Astrocytoma * Oligoastrocytoma * Has undergone surgical resection or biopsy within 35 days after diagnosis of low-grade glioma * Study treatment must begin between 14 days and 4 months after surgical resection or biopsy * Evaluable disease by gadolinium-MRI PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL * Creatinine \< 1.5 times upper limit of normal (ULN) * BUN \< 1.5 times ULN * Bilirubin \< 1.5 times ULN * SGOT \< 2.5 times ULN * Alkaline phosphatase \< 2 times ULN * Life expectancy \> 12 weeks * No nonmalignant systemic disease resulting in the patient being a poor medical risk * No acute infection requiring intravenous antibiotics * No frequent vomiting or medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction) * No other concurrent malignancies except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin * Prior malignancies must be in remission for ≥ 5 years * No known HIV positivity * No AIDS-related illness * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior radiotherapy, interstitial brachytherapy, or radiosurgery for low-grade glioma * No prior biological therapy or chemotherapy for low-grade glioma * No other concurrent chemotherapy * No concurrent radiotherapy or biological therapy * No concurrent prophylactic growth factors * No concurrent epoetin alfa * No other concurrent investigational drugs
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Temozolomide
    intervention Names
    1. Drug: temozolomide
    label
    Temozolomide
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Temozolomide
    description
    Chemotherapy
    name
    temozolomide
    other Names
    1. Temodar
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
120
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Assessment of treatment response was determined by MRI in conjunction with neurological examination and steroid requirement assessment derived from Macdonald's criteria. Complete response was defined as complete disappearance of lesion on consecutive MRI scans with stable or improved neuro exam and steroids. Partial response was defined as a 50% reduction in lesion size or that tumor burden was "definitely better" than prior scan with stable or improved neuro exam and steroids.
    measure
    Response Rate (Complete and Partial Response)
    time Frame
    12 months
secondary Outcomes
  1. description
    Progressive disease was defined as definite enlargement of any existing lesion or any new lesion based on modified Macdonald's criteria.
    measure
    Time to Tumor Progression
    time Frame
    time from registration until date of the first documented progression, an average of 1 year
  2. description
    Number of participants with treatment related grade 2-4 adverse events as defined by CTCAE 3.0
    measure
    Safety Profile
    time Frame
    Time from registration up to 13 months
Full study description
brief Summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with supratentorial low-grade glioma.
detailed Description
OBJECTIVES: Primary * Determine the efficacy of temozolomide, defined as response rate (complete and partial response), in patients with supratentorial mixed low-grade glioma. Secondary * Assess the safety profile of temozolomide in patients with supratentorial low-grade glioma. * Assess the time to tumor progression in patients treated with temozolomide. OUTLINE: Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-a00e6b4d0c53beba4a09
      requested nct id
      NCT00313729
      primary nct id
      NCT00313729
      source kind
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      source record id
      Source null
      source file sha256
      119a798b3a8ac773dc927301b40893d7acb58e99507e3cc7b6aa8527b4e6bb63
      payload sha256
      530be266e665b8f1df5e92e10243fa688695a36c2ccf4047e4b1cc9561d0ba46
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-a00e6b4d0c53beba4a09
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00313729
      occurrences
      1. context exact
        NCT00313729
        end
        11
        exact text
        NCT00313729
        start
        0
      offset unit
      unicode_code_points
      query cond
      Pilocytic Astrocytoma
      query disease state id
      ds-pilocytic-astrocytoma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-pilocytic-astrocytoma-000.json
      source file sha256
      119a798b3a8ac773dc927301b40893d7acb58e99507e3cc7b6aa8527b4e6bb63
      source json pointer
      /studies/6/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      af835b2a1a7521d1cecd6c3f164709865e4ef4e494770996e3f0c2b22052f8cc

    Preserved source evidence · Not medical advice